U.S. patent application number 10/106583 was filed with the patent office on 2003-10-02 for sequential heart valve leaflet repair device and method of use.
Invention is credited to Schreck, Stefan.
Application Number | 20030187467 10/106583 |
Document ID | / |
Family ID | 28452522 |
Filed Date | 2003-10-02 |
United States Patent
Application |
20030187467 |
Kind Code |
A1 |
Schreck, Stefan |
October 2, 2003 |
Sequential heart valve leaflet repair device and method of use
Abstract
A heart valve and tissue repair device for independently,
selectively and sequentially grasping heart valve leaflets and
independently, selectively and sequentially applying one or more
fasteners thereto is disclosed. The device includes a leaflet
engaging tip having one or more graspers capable of individually
and sequentially grasping leaflets, and one or more deployable
fasteners capable of fastening the leaflets. An actuation system
for the device individually and selectively controls the graspers
and deploys the one or more fasteners. Vacuum pressure from an
external vacuum source can be used to grasp the leaflets via a
selector system that controls the actuation system so as to
individually and sequentially apply vacuum force to the
graspers.
Inventors: |
Schreck, Stefan; (Vista,
CA) |
Correspondence
Address: |
Edwards Lifesciences LLC
Law Dept.
One Edwards Way
Irvine
CA
92614
US
|
Family ID: |
28452522 |
Appl. No.: |
10/106583 |
Filed: |
March 26, 2002 |
Current U.S.
Class: |
606/150 ;
606/213 |
Current CPC
Class: |
A61B 17/0469 20130101;
A61B 2017/0472 20130101; A61F 2/2409 20130101; A61B 2017/00783
20130101; A61B 17/00234 20130101 |
Class at
Publication: |
606/150 ;
606/213 |
International
Class: |
A61B 017/04 |
Claims
What is claimed is:
1. An apparatus for repairing a heart valve having multiple
leaflets, comprising: a leaflet engaging tip; a leaflet grasping
mechanism positioned on the leaflet engaging tip; a deployable
fastener positioned on the leaflet engaging tip, the fastener
comprising first and second fastening elements; and, an actuation
system in communication with the grasping mechanism and the
fastener, the actuation system having first and second actuation
modes; wherein the actuation system in the first actuation mode is
capable of causing the grasping mechanism to grasp a first leaflet,
deploying the first fastening element into the first leaflet, and
subsequently causing the grasping mechanism to release the first
leaflet; wherein the actuation system in the second actuation mode
is capable of causing the grasping mechanism to grasp a second
leaflet, deploying the second fastening element into the second
leaflet, and subsequently causing the grasping mechanism to release
the second leaflet; and, wherein the actuation system is capable of
independently and sequentially operating in the first and second
actuation modes.
2. The apparatus of claim 1, further comprising multiple fasteners
having multiple fastening elements and wherein the actuation system
is capable of independently and sequentially deploying the multiple
fastening elements into the leaflets.
3. The apparatus of claim 1 for utilizing an external vacuum
source: wherein the grasping mechanism comprises a vacuum port;
wherein the actuation system is in fluid communication with both
the vacuum port and the vacuum source; and, wherein the actuation
system is capable of selectively restricting or transmitting vacuum
force from the vacuum source to the vacuum port; whereby the
grasping mechanism can grasp a leaflet by applying vacuum force
thereto.
4. The apparatus of claim 3 wherein the vacuum port comprises at
least one vacuum vane, the vacuum vane capable of directing vacuum
force through the vacuum port while supporting a leaflet attached
thereto.
5. The apparatus of claim 3 wherein the vacuum port comprises a
fastener catch, the fastener catch capable of engaging and
retaining the fastening elements.
6. The apparatus of claim 1 for utilizing an external vacuum
source: wherein the grasping mechanism comprises first and second
vacuum ports; wherein the actuation system is in fluid
communication with the vacuum ports and the vacuum source; wherein
the actuation system in the first actuation mode is capable of
selectively restricting or transmitting vacuum force from the
vacuum source to the first vacuum port; and, wherein the actuation
system in the second actuation mode is capable of selectively
restricting or transmitting vacuum force from the vacuum source to
the second vacuum port; whereby the grasping mechanism can
independently and sequentially grasp individual leaflets by
applying vacuum force thereto.
7. The apparatus of claim 6: wherein the actuation system comprises
a user-operable selector capable of being placed in a first
position that places the actuation system in the first actuation
mode and a second position that places the actuation system in the
second actuation mode.
8. The apparatus of claim 7: wherein the actuation system further
comprises a user-operable vacuum actuator having an open position
in which vacuum force is transmitted to a selected port and a
closed position in which the vacuum force is isolated from the
ports.
9. The apparatus of claim 8 wherein the actuation system further
comprises a user-operable fastener actuator capable of deploying
the fastening elements.
10. The apparatus of claim 9: wherein the selector is coupled to
the fastener actuator such that when the selector is in the first
position the fastener actuator is coupled to and capable of
deploying the first fastening element; and, wherein the selector is
coupled to the fastener actuator such that when the selector is in
the second position the fastener actuator is coupled to and capable
of deploying the second fastening element.
11. The apparatus of claim 10 wherein the fastener actuator
comprises a user-operable trigger mechanism coupled to a force
transmitter, and wherein the selector selectively couples the force
transmitter with the first or second fastening element.
12. The apparatus of claim 6 wherein each vacuum port comprises at
least one vacuum vane, the vacuum vane capable of directing the
vacuum force through the vacuum port while supporting a leaflet
attached thereto.
13. The apparatus of claim 6 wherein each vacuum port further
comprises a fastener catch, the fastener catch capable of engaging
and retaining the fastening elements.
14. The apparatus of claim 13 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
15. The apparatus of claim 1 wherein the actuation system further
comprises a user-operable fastener actuator capable of deploying
the fastening elements.
16. The apparatus of claim 15: wherein the actuation system
comprises a user-operable selector capable of being placed in a
first position that places the actuation system in the first
actuation mode and a second position that places the actuation
system in the second actuation mode; wherein the selector is
coupled to the fastener actuator such that when the selector is in
the first position the fastener actuator is coupled to and capable
of deploying the first fastening element; and, wherein the selector
is coupled to the fastener actuator such that when the selector is
in the second position the fastener actuator is coupled to and
capable of deploying the second fastening element.
17. The apparatus of claim 16 wherein the fastener actuator
comprises a trigger mechanism coupled to a force transmitter, and
wherein the selector selectively couples the force transmitter with
the first or second fastening element.
18. The apparatus of claim 16 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
19. The apparatus of claim 1 wherein the deployable fastener is
selected from the group consisting of needles, sutures, staples,
buttons, tissue-graspers, tissue clasps, and barbs.
20. The apparatus of claim 1 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
21. The apparatus of claim 1 further comprising: an elongated body
in communication with the tissue engaging tip; a handle portion in
communication with the elongated body; and, a user-operable
selector coupled to the handle and capable of being placed in a
first position that places the actuation system in the first
actuation mode and a second position that places the actuation
system in the second actuation mode.
22. The apparatus of claim 21 wherein the elongated body is
rigid.
23. The apparatus of claim 21 wherein the elongated body is
flexible.
24. The apparatus of claim 21 wherein the elongated body contains
at least one conduit therein.
25. An apparatus for repairing a heart valve having multiple
leaflets, comprising: a leaflet engaging tip; at least two leaflet
grasping mechanisms positioned on the leaflet engaging tip; at
least one deployable fastener positioned on the leaflet engaging
tip, the fastener comprising at least two fastening elements; and,
an actuation system in communication with the grasping mechanism
and the fastener, the actuation system having at least two
actuation modes; wherein the actuation system in a first actuation
mode is capable of causing a first grasping mechanism to grasp a
first leaflet, deploying a first fastening element into the first
leaflet, and subsequently causing the first grasping mechanism to
release the first leaflet; wherein the actuation system in the
second actuation mode is capable of causing a second grasping
mechanism to grasp a second leaflet, deploying a second fastening
element into the second leaflet, and subsequently causing the
second grasping mechanism to release the second leaflet; and,
wherein the actuation system is capable of independently and
sequentially operating in the first and second actuation modes.
26. The apparatus of claim 25, further comprising multiple
fasteners having multiple fastening elements and wherein the
actuation system is capable of independently and sequentially
deploying the multiple fastening elements into multiple
leaflets.
27. The apparatus of claim 25 for utilizing an external vacuum
source: wherein each grasping mechanism comprises a vacuum port;
wherein the actuation system is in fluid communication with the
vacuum ports and the vacuum source; and, wherein the actuation
system is capable of independently and sequentially restricting or
transmitting vacuum force from the vacuum source and each vacuum
port; whereby each grasping mechanism can independently and
sequentially grasp individual leaflets by applying vacuum force
thereto.
28. The apparatus of claim 27: wherein the actuation system
comprises a user-operable selector capable of being placed in a
first position that places the actuation system in the first
actuation mode and a second position that places the actuation
system in the second actuation mode.
29. The apparatus of claim 28: wherein the actuation system further
comprises a user-operable vacuum actuator having an open position
in which vacuum force is transmitted to a selected port and a
closed position in which the vacuum force is isolated from the
ports.
30. The apparatus of claim 29 wherein the actuation system further
comprises a user-operable fastener actuator capable of deploying
the fastening elements.
31. The apparatus of claim 30: wherein the selector is coupled to
the fastener actuator such that when the selector is in the first
position the fastener actuator is coupled to and capable of
deploying the first fastening element; and, wherein the selector is
coupled to the fastener actuator such that when the selector is in
the second position the fastener actuator is coupled to and capable
of deploying the second fastening element.
32. The apparatus of claim 31 wherein the fastener actuator
comprises a user-operable trigger mechanism coupled to a force
transmitter, and wherein the selector selectively couples the force
transmitter with the first or second fastening element.
33. The apparatus of claim 27 wherein each port comprises at least
one vacuum vane, the vacuum vane capable of directing the vacuum
force through the vacuum port while supporting a leaflet attached
thereto.
34. The apparatus of claim 27 wherein each vacuum port further
comprises a fastener catch, the fastener catch capable of engaging
and retaining the fastening elements.
35. The apparatus of claim 34 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
36. The apparatus of claim 25 wherein the actuation system further
comprises a user-operable fastener actuator capable of deploying
the fastening elements.
37. The apparatus of claim 36 wherein the actuation system
comprises a user-operable selector capable of being placed in a
first position that places the actuation system in the first
actuation mode and a second position that places the actuation
system in the second actuation mode; wherein the selector is
coupled to the fastener actuator such that when the selector is in
the first position the fastener actuator is coupled to and capable
of deploying a first fastening element; and, wherein the selector
is coupled to the fastener actuator such that when the selector is
in the second position the fastener actuator is coupled to and
capable of deploying a second fastening element.
38. The apparatus of claim 37 wherein the fastener actuator
comprises a trigger mechanism coupled to a force transmitter, and
wherein the selector selectively couples the force transmitter with
the first or second fastening element.
39. The apparatus of claim 38 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
40. The apparatus of claim 25 wherein the deployable fastener is
selected from the group consisting of needles, sutures, staples,
buttons, tissue-graspers, tissue clasps, and barbs.
41. The apparatus of claim 25 wherein the deployable fastener
comprises a length of suture material and the fastening elements
comprise needles connected to opposite ends of the suture
material.
42. A method of repairing a heart valve having multiple leaflets,
comprising: stabilizing a first leaflet with the repair device;
deploying a first fastener element into the stabilized first
leaflet; disengaging the first leaflet from the repair device while
leaving the first fastener element deployed therein; stabilizing a
second leaflet with the repair device; deploying a second fastener
element into the second leaflet; disengaging the second leaflet
from the repair device while leaving the second fastener element
deployed therein; and joining the first and second leaflets by
reducing the distance between the first and second fastener
elements.
43. The method of claim 42 further comprising controllably and
selectively stabilizing the first and second leaflets with vacuum
force.
44. The method of claim 42 wherein the first and second fastener
elements are portions of a piece of suture material and wherein the
step of reducing the distance between the first and second fastener
elements is performed by tying the suture material into a knot.
45. The method of claim 42 further comprising adjusting the
position of the repair device relative to the leaflets by
monitoring fluid pressure around a distal end of the repair
device.
46. The method of claim 45 wherein the adjusting step is performed
while the distal end of the repair device is in an
atrial-ventricular junction and wherein the monitor step is
performed by observing pressure differentials between blood in an
adjacent ventricle and an adjacent atrium.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application discloses subject matter related to
co-pending U.S. patent application Ser. No. 09/562,406, filed May
1, 2000, entitled "Minimally Invasive Mitral Valve Repair Method
And Apparatus", and co-pending U.S. patent application Ser. No.
09/778,392, filed Feb. 6, 2001, entitled "Method and System for
Tissue Repair Using Dual Catheters. The entire disclosures of the
aforementioned United States patent applications are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] In vertebrate animals, the heart is a hollow muscular organ
having four pumping chambers: the left atrium, the left ventricle,
the right atrium and the right ventricle. The atria are isolated
from their respective ventricles by one-way valves located at the
respective atrial-ventricular junctions. These valves are
identified as the mitral (or bicuspid) valve on the left side of
the heart, and tricuspid valve on the right side of the heart. The
exit valves from the left and right ventricles are identified as
the aortic and pulmonary valves, respectively.
[0003] The valves of the heart are positioned in valvular annuluses
that comprise dense fibrous rings attached either directly or
indirectly to the atrial and ventricular muscle fibers. Valve
leaflets comprising flexible collagenous structures are attached
to, and extend inwardly from, the annuluses to meet at coapting
edges. The aortic, tricuspid and pulmonary valves each have three
leaflets, while the mitral valve only has two. In normal operation,
the leaflets of the mitral valve open as left ventricle dilates
thereby permitting blood to flow from the left atrium into the left
ventricle. The leaflets then coapt (i.e. close) during the
contraction cycle of the left ventricle, thereby preventing the
blood from returning to the left atrium and forcing the blood to
exit the left ventricle through the aortic valve. Similarly, the
tricuspid valve regulates flow from the right atrium into the right
ventricle, and the pulmonary valve regulates blood exiting the
right ventricle.
[0004] For a number of clinical reasons various problems with heart
valves can develop. One common form of heart disease involves the
deterioration or degradation of the heart valves which leads to
stenosis and/or insufficiency. Heart valve stenosis is a condition
in which the valve does not open properly. Insufficiency is a
condition in which the valve does not close properly. Insufficiency
of the mitral valve, most common because of the relatively high
fluid pressures in the left ventricle, results in mitral valve
regurgitation ("MR"), a condition in which blood reverses its
intended course and flows "backward" from the left ventricle to the
left atrium during heart contractions.
[0005] A number of surgical techniques have been developed to
repair degraded or otherwise incompetent heart valves. A common
procedure involves replacement of a native aortic or mitral valve
with a prosthetic heart valves. These procedures require the
surgeon to gain access to the heart through the patient's chest (or
possibly percutaneously), surgically remove the incompetent native
heart valve and associated tissue, remodel the surrounding valve
annulus, and secure a replacement valve in the remodeled annulus.
While such procedures can be very effective, there are significant
shortcomings associated with such replacement valves. For example,
the highly invasive nature of the implantation procedure typically
results in substantial patient discomfort and requires patients to
remain hospitalized for extended recovery periods. In addition, the
two basic types of commercially available replacement valves,
mechanical valves and tissue valves, each have shortcomings of
their own. Mechanical replacement valves typically offer extended
operational lifetimes, but the patient is usually required to
maintain a regimen of anti-coagulant drugs for the remainder of his
or her life. Tissue valves typically offer a higher degree of
acceptance by the body which reduces or eliminates the need for
anti-coagulants. However, the operational lifetimes of tissue
valves are typically shorter than mechanical valves and thus may
require a subsequent replacement(s) during the patient's
lifetime.
[0006] As an alternative to prosthetic heart valve replacement, it
is often preferable to remodel the native heart valve and/or
surrounding tissue. Remodeling of the valve often preserves left
ventricular function better than mitral valve replacement because
the subvalvular papillary muscles and chordae tendineae are
preserved (most prosthetic valves do not require these muscles to
operate). Typically, valvular remodeling is accomplished by
implanting a prosthetic ring (a.k.a. "annuloplasty ring") into the
valve annulus to reduce and/or stabilize the structure of the
annulus in order to correct valvular insufficiency. Annuloplasty
rings are typically constructed of a resilient core covered with a
fabric sewing material. Annuloplasty procedures can be performed
alone, or they can be performed in conjunction with other
procedures such as leaflet repair. Although such annuloplasty
procedures have become popular and well accepted, reshaping the
surrounding annulus and traditional leaflet repairs do not always
lead to optimum leaflet coaptation. As a result, some patients may
still experience residual mitral valve regurgitation following such
annuloplasty procedures.
[0007] A recently developed technique known as a "bow-tie" repair
has also been advocated for repairing insufficient heart valves, in
particular the mitral valve. The mitral valve bow-tie technique
involves suturing the anterior and posterior leaflets together near
the middle of their coapting edges, thereby causing blood to flow
through two newly formed side openings. While this does reduce the
volume of blood that can flow from the atrium to the ventricle,
this is compensated by improved leaflet coaptation which reduces
mitral regurgitation. This process as originally developed by Dr.
Ottavio Alfieri involved arresting the heart and placing the
patient on extracorporeal bypass and required invasive surgery to
access and suture the leaflets together. More recently, however,
some have advocated a "beating heart" procedure in which the heart
is accessed remotely and remains active throughout the bow-tie
procedure.
[0008] A particular method for performing a beating heart bow-tie
procedure (i.e. without extracorporeal bypass) has been proposed by
Dr. Mehmet Oz, of Columbia University. A method and device for
performing the method are described in PCT publication WO 99/00059,
published Jan. 7, 1999. In one embodiment of the disclosed
procedure, the associated device consists of a forceps-like grasper
used to grasp and hold the mitral valve leaflets in a coapted
position for the suturing step. Since the mitral valve leaflets
meet and curve toward and slightly into the left ventricular cavity
at their mating edges, the grasper device is passed through a
sealed aperture in the apex of the left ventricle. The edges of the
mating mitral valve leaflets are then grasped and held together,
and a fastening device such as a clip or suture is utilized to
fasten them. The fastening devices should be applied to the leaflet
tissue with sufficient tissue purchase to prevent tearout or other
failure, but close enough to the edges to ensure that the newly
created side holes are as large as possible. The Mehmet Oz
disclosure thus teaches that teeth of the grasper device can be
linearly slidable with respect to one another so as to permit
alignment of the mitral valve leaflets prior to fastening. Since
the procedure is done on a beating heart, it will be readily
understood that the pressures and motions within the left ventricle
and mitral valve leaflets are severe. Thus the procedure taught by
Dr. Mehmet Oz is very skill-intensive.
[0009] The bow-tie technique has proved to be a viable alternative
for treating otherwise incompetent heart valves. Nonetheless,
several shortcomings associated with the current bow-tie procedures
have been identified. Current systems include devices having
mechanical graspers, barbed members, and vacuum devices that
simultaneously capture and retain the valve leaflets prior to
applying a fastening device thereto. Often, use of these devices
results in the less than optimal leaflet stabilization and fastener
placement. Many of these problems arise from the fact that the
surgeon is required to capture, retain and fasten the leaflets in
one relatively inflexible procedure. These difficulties are
compounded when the leaflets are small or calcified making them
difficult to pull together, and in beating heart procedures in
which the leaflets are actively functioning throughout the surgery.
In light of the foregoing, there is presently a need for improved
systems for stabilizing multiple tissue heart valve leaflets and
placing a fastening device therebetween. More specifically, there
is a present need for an improved bow-tie procedure for repairing a
patient's mitral valve.
SUMMARY OF THE INVENTION
[0010] The present invention provides a device capable of
effectively stabilizing at least one heart valve leaflets, or
portions of a single leaflet, and applying a fastener thereto.
Those skilled in the art will appreciate that the present invention
enables a user to apply such a fastener in vivo to a remote
location within the patient's heart.
[0011] In one aspect, the repair device of the present invention
comprises a leaflet engaging tip, a leaflet grasping mechanism
positioned on the leaflet engaging tip, a deployable fastener
positioned on the leaflet engaging tip, and an actuation system in
communication with the grasping mechanism and the fastener. The
actuation system has at least two actuation modes and is capable of
independently and sequentially operating in each actuation mode. In
the first actuation mode the actuation system is capable of causing
the grasping mechanism to grasp a first leaflet, deploying a first
fastening element into the first leaflet, and subsequently causing
the grasping mechanism to release the first leaflet. In the second
actuation mode the actuation system is capable of causing the
grasping mechanism to grasp a second leaflet, deploying a second
fastening element into the second leaflet, and subsequently causing
the grasping mechanism to release the second leaflet.
[0012] In another aspect, the present invention comprises multiple
fasteners having multiple fastening elements and wherein the
actuation system is capable of independently and sequentially
deploying the multiple fastening elements into the leaflets.
[0013] In another aspect, the present invention utilizes an
external vacuum source to enable the grasping mechanism to grasp a
leaflet by applying vacuum force thereto. In this aspect the
grasping mechanism comprises a vacuum port, the actuation system is
in fluid communication with both the vacuum port and the vacuum
source, and the actuation system is capable of selectively
restricting or transmitting vacuum force from the vacuum source to
the vacuum port.
[0014] In another aspect, the present invention comprises one or
more vacuum ports, each having at least one vacuum vane capable of
directing vacuum force through the vacuum port while supporting a
leaflet attached thereto.
[0015] In another aspect, the present invention includes one or
more vacuum ports, each having a fastener catch capable of engaging
and retaining the fastening elements.
[0016] In another aspect, the present invention utilizes an
external vacuum source to enable the grasping mechanism to
independently and sequentially grasp leaflets by applying vacuum
force to multiple vacuum ports. In this aspect the grasping
mechanism comprises first and second vacuum ports, the actuation
system is in fluid communication with the vacuum ports and the
vacuum source. In a first actuation mode the actuation system is
capable of selectively restricting or transmitting vacuum force
from the vacuum source to the first vacuum port and, in a second
actuation mode the actuation system is capable of selectively
restricting or transmitting vacuum force from the vacuum source to
the second vacuum port.
[0017] In a related aspect, the present invention comprises a
user-operable selector capable of being placed in a first position
that places an actuation system in a first actuation mode and a
second position that places the actuation system in the second
actuation mode.
[0018] In a related aspect, the present invention comprises a
user-operable vacuum actuator having an open position in which
vacuum force is transmitted from a vacuum source to a selected port
and a closed position in which vacuum force is isolated from the
ports.
[0019] In another aspect, the present invention comprises at least
one deployable fastener comprising a length of suture material and
fastening elements comprising needles connected to opposite ends of
the suture material.
[0020] In another aspect, the present invention comprises an
actuation system having a user-operable fastener actuator capable
of individually and sequentially deploying fastening elements.
[0021] In another aspect, the present invention comprises an
actuation system coupled to a user-operable selector capable of
being placed in multiple positions. In a first position the
selector places the actuation system in a first actuation mode, and
a second position the selector places the actuation system in a
second actuation mode.
[0022] In another aspect, the present invention comprises a
selector and fastener actuator having a trigger mechanism coupled
to a force transmitter. In this aspect, a selector selectively
couples the force transmitter with a first or second fastening
element.
[0023] In another aspect, the present invention comprises at least
one deployable fastener selected from the group consisting of
needles, sutures, staples, buttons, tissue-graspers, tissue clasps,
and barbs.
[0024] In another aspect, the present invention comprises an
elongated body in communication with a tissue engaging tip, a
handle portion in communication with the elongated body, and a
user-operable selector coupled to the handle and capable of being
placed in multiple positions. Placing the selector in a first
position places an actuation system in a first actuation mode; and,
placing the selector in a second position places the actuation
system in the second actuation mode. In a related aspect, the
present invention comprises a rigid elongated body.
[0025] In a related aspect, the present invention comprises a
flexible elongated body.
[0026] In a related aspect, the present invention comprises an
elongated body having at least one conduit therein.
[0027] In another aspect, the repair device of the present
invention comprises a leaflet engaging tip, at least two leaflet
grasping mechanisms positioned on the leaflet engaging tip, at
least one deployable fastener having multiple fastening elements
positioned on the leaflet engaging tip, and an actuation system in
communication with the grasping mechanism and the fastener. The
actuation system has at least two actuation modes and is capable of
independently and sequentially operating in each actuation mode. In
the first actuation mode the actuation system is capable of causing
a first grasping mechanism to grasp a first leaflet, deploying a
first fastening element into the first leaflet, and subsequently
causing the first grasping mechanism to release the first leaflet.
In the second actuation mode the actuation system is capable of
causing a second grasping mechanism to grasp a second leaflet,
deploying a second fastening element into the second leaflet, and
subsequently causing the second grasping mechanism to release the
second leaflet.
[0028] In another aspect, the present invention utilizes an
external vacuum source to enable multiple grasping mechanisms to
grasp leaflets by applying vacuum force thereto. In this aspect
each grasping mechanism comprises a vacuum port, the actuation
system is in fluid communication with each vacuum port and the
vacuum source, and the actuation system is capable of selectively
restricting or transmitting vacuum force from the vacuum source to
each vacuum port.
[0029] In another aspect, the present invention discloses a method
of repairing a heart valve having multiple leaflets. The method
includes stabilizing a first leaflet with the repair device,
deploying a first fastener element into the stabilized first
leaflet, disengaging the first leaflet from the repair device while
leaving the first fastener element deployed therein, stabilizing a
second leaflet with the repair device, deploying a second fastener
element into the second leaflet, disengaging the second leaflet
from the repair device while leaving the second fastener element
deployed therein, and joining the first and second leaflets by
reducing the distance between the first and second fastener
elements. Additional leaflet portions may also be attached in a
similar manner.
[0030] In another aspect, the present invention discloses a method
of controllably and selectively stabilizing multiple heart valve
leaflets with vacuum force.
[0031] In another aspect, the present invention discloses a method
of stabilizing multiple heart valve leaflets with a piece of suture
material by first fastening the suture material to the leaflets and
then tying the suture material into a knot.
[0032] In another aspect, the present invention comprises a method
of adjusting the position of a repair device relative to a heart
valve by monitoring fluid pressure around a distal end of the
repair device.
[0033] In another aspect, the present invention comprises a method
of adjusting the position of a repair device relative to an
atrial-ventricular junction by observing pressure differentials
between blood in an adjacent ventricle and an adjacent atrium.
[0034] Other objects, features, and advantages of the present
invention will become apparent from a consideration of the
following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] The apparatus of the present invention will be explained in
more detail by way of the accompanying drawings, wherein:
[0036] FIG. 1 shows a perspective view of the repair device of the
present invention;
[0037] FIG. 2 shows a perspective view of handle portion of the
repair device of the present invention;
[0038] FIG. 3 shows a perspective cross-sectional view of the
internal components located within the handle portion of the repair
device of the present invention;
[0039] FIG. 4 shows a perspective view of the vacuum system of the
repair device of the present invention;
[0040] FIG. 5 shows a perspective view of the trigger assembly of
the repair device of the present invention prior to actuation;
[0041] FIG. 6 shows a perspective view of the trigger assembly of
the repair device of the present invention during actuation;
[0042] FIG. 7 shows a perspective view of the vacuum actuation
assembly of the repair device of the present invention;
[0043] FIG. 8 shows a perspective view of the vacuum actuation
assembly of the repair device of the present invention positioned
within the handle portion;
[0044] FIG. 9 shows a side view of the vacuum actuation assembly of
the repair device of the present invention positioned within the
handle portion;
[0045] FIG. 10 shows a perspective view of the exterior of the
elongated body and tissue engaging tip of the repair device of the
present invention;
[0046] FIG. 11 shows a perspective view of the internal components
of the elongated body of the repair device of the present
invention; and
[0047] FIG. 12 shows a perspective view of the internal components
of the engaging tip of the repair device of the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0048] Disclosed herein is a description of various illustrated
embodiments of the present invention. This description is not to be
taken in a limiting sense, but is made merely for the purpose of
illustrating the general principles of the invention. The section
titles and overall organization of the present description are for
the purpose of convenience only and do not limit the present
invention.
[0049] The methods and devices of the present invention were
primarily designed for use in the surgical treatment of heart
valves. As those skilled in the art will appreciate, the exemplary
sequential repair device disclosed herein is designed to minimize
trauma to the patient before, during, and subsequent to a surgical
procedure, while providing improved heart valve leaflet
stabilization and enhanced placement of a fastening device thereon.
The repair device of the present invention is particularly useful
in repairing dysfunctional mitral valves by stabilizing the
discrete valvular tissue pieces of the anterior and posterior
leaflets and deploying a fastening device(s) thereto.
[0050] FIG. 1 shows the sequential repair device of the present
invention. As illustrated, the repair device 10 comprises a handle
portion 12 in communication with an elongated body 14. A leaflet
engaging tip 16 is positioned on the distal portion of the
elongated body 14. Those skilled in the art will appreciate that
the present invention may be manufactured from a plurality of
materials including, without limitation, various metals, plastics,
thermoplastics, silicones, elastomers, ceramics, composite
materials, or various combinations of the aforementioned materials.
For example, the handle portion 12 may be manufactured from
acrylic, while the elongated body 14 may be manufactured from
stainless steel.
[0051] FIG. 2 shows a perspective view of the handle portion 12. As
shown in FIG. 2, the handle portion 12 comprises a grip portion 18
in communication with a housing body 20. The grip portion 18
includes a trigger recess 22 capable of receiving a trigger 24
therein. A trigger guide 26 is positioned proximate to the trigger
recess 22. In addition to supporting the trigger 24, the trigger
guide 26 isolates the trigger 24 from the grip portion 18 thereby
preventing the accidental actuation of the trigger 24. In one
embodiment, the grip portion 18 is perpendicularly attached to the
housing body 20, thereby forming a pistol-type grip. Those skilled
in the art will appreciate that the handle portion 14 of the
present invention may be manufactured in a plurality of shapes as
desired by the operator. At least one external conduit recess 28
capable of receiving at least one external conduit 30 therein may
be formed on the repair device 10.
[0052] The handle portion 12 further comprises a vacuum actuator
recess 32 capable of receiving a vacuum actuator 34 and a vacuum
selector 36 therein. As shown in FIG. 2, the vacuum actuator recess
32 may be positioned adjacent to the trigger recess 22 thereby
permitting the user to single-handedly operate the vacuum actuator
34, the vacuum selector 36, and the trigger 24 simultaneously. In
an alternate embodiment, the vacuum actuator recess 32 may be
positioned remotely from the trigger recess 22 to prevent the
accidental actuation of the vacuum actuator 34 or the vacuum
selector 36.
[0053] An elongated body aperture 38 capable of receiving the
elongated body 14 therein is formed in the housing body 20. At
least one coupling member receiver 40 capable of receiving at least
one coupling member 42 therein is formed in the housing body 20
proximate to the elongated body aperture 38 to effect coupling of
the elongated body 14 to the handle portion 12. Those skilled in
the art will appreciate that the at least one coupling member 42
may include, without limitation, screws, rivets, pins, or locking
members, thereby permitting the elongated body 14 to be detachable
from the handle portion 12. In another embodiment, the elongated
body 14 may be permanently attached to handle portion 12 with in a
plurality of ways, such as welding or gluing.
[0054] FIGS. 3 and 7 show the internal components in more detail.
As shown in FIG. 3 the handle portion may be split into two hollow
halves comprising a first handle portion 12A and a second handle
portion 12B which cooperatively form a handle cavity 44 and a
housing cavity 46 within the handle portion 12. At least one
assembly device receiver 48 capable of receiving at least one
assembly device (not shown) therein may be formed, e.g. molded, in
the first and/or second handle portions 12A, 12B. Exemplary
assembly devices include, but are not limited to, screws, rivets,
assembly pins or adhesives.
[0055] FIGS. 3 and 4 show vacuum system 50. An external vacuum
conduit 52, positioned within the at least one external conduit
recess 28 formed in the repair device 10, is attached to a
compressible main vacuum line 54 through a vacuum coupler 56. The
external vacuum conduit 52 is in communication with a vacuum source
(not shown), thereby providing suction (i.e. vacuum pressure) to
the repair device 10. In addition, an external positioning conduit
58 is positioned within the at least one external conduit recess 28
and is attached to an internal positioning line 60 through a
positioning coupler 62. The external positioning conduit 58 may be
in communication with a positioning system. In one embodiment, the
external positioning conduit 58 may be in communication with a
pressure sensing device. Those skilled in the art will appreciate
that a pressure sensing device can be used to assist the user in
the precise placement of the repair device 10 within the patient
based on a determination of pressure levels within the various
parts of the body. For example, such a pressure sensing system
would assist the user in determining the position of the leaflet
engaging tip 16 of the repair device 10 relative to the
atrial-ventricular junction of the patient's heart by sensing
variations in the internal pressure between the atrium and the
ventricle. In other embodiments, the present invention may be
easily adapted to utilize a plurality of alternate positioning
systems, including, without limitation, optical systems, ultrasonic
systems, echogenic systems, microwave positioning systems,
radio-frequency positioning systems, or radio-opaque positioning
devices.
[0056] As shown in FIGS. 3 and 4, the main vacuum line 54 is
attached to a vacuum manifold 64 through a vacuum coupler 66. The
internal positioning line 60 is similarly attached to the vacuum
manifold 64 through a positioning line coupler 68. The vacuum
manifold 64 includes a first vacuum conduit coupler 70 capable of
coupling to a first vacuum conduit 72 and a second vacuum conduit
coupler 74 capable of coupling to a second vacuum conduit 76
thereby permitting the first and second vacuum conduits 72, 76 to
communicate with the main vacuum line 54. A positioning conduit 78
is attached to the vacuum manifold 64 through a positioning coupler
80, thereby permitting the positioning conduit 78 to communicate
with the internal positioning line 60. The first vacuum conduit 72
attaches to the first elongated body vacuum conduit 82 through a
coupling member 84. Similarly, the second vacuum conduit 76 is
attached to a second elongated body vacuum conduit 86 through a
coupling member 88.
[0057] FIGS. 3, 5, and 6 show the various components comprising
trigger assembly 90. The trigger assembly 90 includes a trigger rod
92 which in communication with the trigger 24 and includes a bias
member 94, illustrated as a spring, positioned thereon. A trigger
safety 96 is positioned proximate to the trigger 24 and comprises a
safety body 98 having a safety actuator 100 located thereon and a
trigger catch 102 capable of engaging the trigger 24. The trigger
safety 96 is coupled to the repair device 10 with an attachment
member 104. An actuation tray 106 having an attachment unit 108 is
attached thereto is in communication with the trigger 24. FIG. 6
shows the trigger assembly 90 during actuation. As shown, during
actuation the trigger safety 96 is forced to deflect downwardly by
the vacuum actuator (not shown in this figure), thereby causing the
trigger catch 102 to disengage the trigger 24. The trigger safety
96 enters the internal cavity 110 formed in the trigger 24 thereby,
permitting the user to actuate the trigger 24 rearwardly, which
results in compression of the bias member 94. Once the actuation
pressure on the trigger has been released, the bias member biases
the trigger 24 to a non-actuated position, thereby permitting the
trigger catch 102 to re-engage the trigger 24. Those skilled in the
art will appreciate the trigger safety 90 may be manufactured from
a plurality of materials having sufficient resiliency to permit the
repeated deflection thereof without a substantial loss of
resiliency.
[0058] FIGS. 3, 7, and 8 show the various components comprising
vacuum actuator assembly 112. As shown, the vacuum actuator
assembly 112 includes a vacuum actuator 34 and a vacuum selector 36
positioned on or proximate to a vacuum actuator 34. For example, a
vacuum selector port 114 capable of receiving the vacuum selector
36 therein may be formed in the vacuum actuator 34. The vacuum
selector 36, which is capable of a first position and a second
position, is in communication with a vacuum selector shaft 115
which includes a selector pivot 116, which attaches the vacuum
selector shaft to the housing body 20, and an attachment orifice
118 located near the distal end thereof. Compression member 120
capable of engaging and compressing the main vacuum line 54 is in
communication with the vacuum actuator 34. Vacuum bias member 122
biases the vacuum actuator 34 outwardly. Ideally, the bias member
122 applies sufficient outward force to the vacuum actuator 34 to
enable the compression member 120 to compressively squeeze the main
vacuum line 54 against a stop, in this case the housing 12, to seal
the main vacuum line. Those skilled in the art will appreciate that
the application of inward force by the user to the vacuum actuator
34 results in the compression of the vacuum bias member 122 and
causes the compression member 120 to move inwardly thereby
disengaging and unsealing the main vacuum line 54. As the inward
movement of the vacuum actuator 34 continues the compression member
120 engages the safety actuator 100 located on the trigger safety
body 98, thereby causing the trigger safety 96 to deflect
downwardly which in turn permits full actuation of the trigger 24.
Thus, according to the illustrated embodiment, the trigger 24 may
be actuated only when the vacuum actuator 34 is actuated.
[0059] FIGS. 3, 8, and 9 show the components of the force
transmission system 124. The force transmission system 124
comprises a selector toggle 126 which is attached to or otherwise
in communication with the attachment orifice 118 located on the
vacuum selector shaft 114. The selector toggle 126 further includes
a biasing member 128 positioned thereon, and a pivoting attachment
member 130 to pivotally couple the selector toggle to the housing
body 20. The force transmission system 124 further comprises a
transmission bridge 132 which is in communication with the selector
toggle 126. A first connecting rod 134 is attached to the
transmission bridge 132 with a pivot pin 136. Similarly, a second
connecting rod 138 is attached to the transmission bridge 132 with
a pivot pin 140. The first and second connecting rods 134, 138 are
connected to a first and second connecting rod mount 144, 150
located on a rocker bridge 142. The rocker bridge 142 is in
communication with a first and second pivoting actuation member
catches 146, 152, which are attached to the attachment unit 108 of
the trigger actuation tray 106 with pins 148, 154. At least one
actuation member is capable of engaging the first and second
pivoting catches 146, 152. As shown in the present embodiment,
first and second actuation members or rods 156, 158 each include at
least one actuation flange 160 positioned thereon thereby forming a
first capture region 162 on the first actuation member 156 and a
second capture region 164 on the second actuation member 158 which
are located proximate to the first and second actuation member
catches 146, 152. The distal portion of the each actuation member
156, 158 is in communication with the leaflet engaging tip 16
through the elongated body 14. The proximal portion of the first
and second actuation members 156, 158 includes a biasing members
166, 168, respectively. A support member 65, positioned on the
vacuum manifold 64 supports the bias members 166, 168 and receives
the actuation members 156, 158 during actuation.
[0060] FIG. 10 shows the external components of the elongated body
14 and the leaflet engaging tip 16. The elongated body 14 may be
manufactured from a plurality of materials in various widths and
length. Those skilled in the art will appreciate that the elongated
body 14 can comprise a rigid body or, in the alternative, may be
manufactured from a flexible material thereby enabling the repair
device 10 to be delivered through a catheter to a repair site in
vivo. As shown in FIG. 10, the outer surface of the elongated body
14 comprises an outer sheath 170 capable of coupling to the handle
portion 12. A guidewire retainer (not shown) may be included on the
exterior surface of the outer sheath 170, the guidewire retainer
(not shown) capable of engaging a guidewire (not shown) for
catheter based surgical procedures. A tip retainer 172 is located
on the distal portion of the outer sheath 170 of the elongated body
14. The tip retainer 172 is adapted to engage and retain the
attachment device 174 of the tip engaging tip 16. Those skilled in
the art will appreciate that the tip retainer 172 may include screw
receivers, ports, snap fit members, or threads adapted to receive
the leaflet engaging tip 16.
[0061] As shown in FIG. 10, the external components of the leaflet
engaging tip 16 include a proximal portion 178 and a distal portion
180. A first and second engaging channel 182, 184 separate the
proximal portion 178 from the distal portion 180. The proximal
portion 178 includes a first port or vacuum recess 186 located
within the first engaging channel 182. Similarly, a second port or
vacuum recess 188 is located within the second engaging channel
184. The proximal portion 178 also includes a mounting member 190
capable of being sealably received within the elongated body 14,
thereby effectively coupling the leaflet engaging tip 16 to the
elongated body 14. The attachment device 174 may be located on or
otherwise in communication with the mounting member 190 to
effectuate the coupling process. Those skilled in the art will
appreciate that the leaflet engaging tip 16 of the present
invention may be attached to the elongated body 14 in a plurality
of ways including, without limitation, detachably coupled or
permanently attached.
[0062] The distal portion 180 of the leaflet engaging tip 16
includes a first and second actuation ports 194, 196 located within
the first and second engaging channel 182, 184. The actuation ports
194, 196 located on the distal portion 180 are capable of passing
at least one fastening device (not shown in FIG. 11)
therethrough.
[0063] FIG. 11 shows the internal components of the elongated body
14. As shown in FIG. 11, a first and second elongated body vacuum
conduits 82, 86, respectively, and a first and second actuation
members 156, 158 are located within an inner lumen 176 formed by
the outer sheath 170. The first and second elongated body vacuum
conduits 82, 86 are in fluid communication with the first and
second vacuum conduits 72, 76 located within the housing body 20 of
the handle portion 12. Similarly, the first and second actuation
members 156, 158 are in communication with the force transmission
system 124 positioned within the housing body 20 of the handle
portion 12. The positioning conduit 78 may be positioned within the
elongated body inner lumen 176.
[0064] FIG. 12 shows the internal components of the leaflet
engaging tip 16 of the present invention. A first vacuum recess
device 198, which is located within the first vacuum recess 186,
includes a vane member 200 capable of directing suction force
through the first vacuum recess 186. At least one first fastener
catch 202 is formed on or otherwise in communication with the first
vacuum recess device 198. The at least one first fastener catch 202
is capable of receiving and retaining therein at least fastener
device (described in more detail below). Similarly, the second
vacuum recess device 204, which is located within the second vacuum
recess 188, includes a vane member 206 capable of directing suction
force through the second vacuum recess 188. At least one second
fastener catch 208 is formed on or otherwise in communication with
the second vacuum recess device 204. The at least one second
fastener catch 208 is capable of receiving and retaining at least
fastener device therein.
[0065] First and second vacuum ports 210, 212 (210 not visible) are
located within the first and second vacuum recesses 186, 188. The
first vacuum port 210 is in fluid communication with the first
elongated body vacuum conduit 82, while the second vacuum port 212
is in fluid communication with the second elongated body vacuum
conduit 86. A positioning port 213 in fluid communication with the
positioning conduit 78 may be positioned on the proximal portion
178 or on the distal portion 180 of the engaging tip 16.
[0066] As shown in FIG. 12, the distal portion 180 of the leaflet
engaging tip 16 communicates with the proximal portion 178 thereof
through the first and second actuation members 156, 158. The first
actuation device 214 is in communication with the first actuation
member 156, while the second actuation device is in communication
with the second actuation member 158. The first actuation device
214 comprises at least one fastener device 218 positioned thereon.
The at least one fastener device 218 is capable of engaging the at
least one first catch 202 located within the first vacuum recess
186. Similarly, the second actuation device 216 comprises at least
one fastener device 220 positioned thereon. The at least one
fastener device 220 is capable of engaging the at least one second
catch 208 located within the second vacuum recess 188. The
illustrated embodiment shows each actuation device 214, 216,
respectively, having two fastener devices 218, 220, respectively,
mounted thereon. Those skilled in the art will appreciate that the
present invention may be manufactured with a one or more fastener
devices located on the actuation devices 214, 216. The fastener
devices 218, 220 may be attached to suture material (not shown)
positioned within the actuation devices 214, 216. It will be
appreciated that the actuation devices 214, 216 of the present
invention may be actuated independently. In addition, the
illustrated embodiment includes needles and suture material as
tissue fasteners, but those skilled in the art will appreciate that
the invention may be easily adapted to apply a plurality of
fasteners. Exemplary fasteners include staples, graspers, buttons,
and toggles.
[0067] Also disclosed herein is a method of using the sequential
repair device of the present invention to repair discreet heart
valve leaflets in vivo. While those skilled in the art will
appreciate that the present invention may be adapted for use in
many procedures throughout a patient's body, the inventive repair
device 10 is particularly well suited for procedures to repair
dysfunctional heart valves without requiring the patient's heart to
be arrested. Following is a description of the inventive method for
such a repair of a dysfunctional heart valve.
[0068] To use the present invention, the external vacuum conduit 52
and external positioning conduit 58 are connected to an external
vacuum source (not shown) and a selected positioning device.
Thereafter, the operator gains access to the repair site in vivo.
For example, in procedures involving the heart, one approach to the
heart requires the patient be positioned for a left anterolateral
thoracotomy. An incision is made in the patient's chest and the
chest is entered through the bed of the fifth rib. The pericardium
is incised posterior and parallel to the left phrenic nerve, such
that the incision extends from the left pulmonary artery to the
apex of the left ventricle. Thereafter, a sealing cannula may be
positioned on the exterior atrial wall of the patient's heart. An
exemplary sealing cannula is described in U.S. patent application
Ser. No. 09/800,390, entitled "Sealing Access Cannula System",
filed on March 5, 2001, which is incorporated herein by reference.
An incision is made in the atrial tissue once the sealing cannula
is sufficiently anchored to the heart wall. The leaflet engaging
tip 16 of the present invention then inserted into the sealing
cannula and advanced to a position proximate the mitral valve.
[0069] One embodiment of the present invention includes a pressure
transducer as a positioning device. The surgeon may determine the
position of the leaflet engaging tip 16 with respect to the mitral
valve based on various pressure readings from the pressure
transducer. For example, the operator may determine the position of
the leaflet engaging tip 16 with respect to the mitral valve by
observing the pressure differential between the atrium and the
ventricle, as ventricular pressure within the heart is considerably
greater than the pressure within the atrium.
[0070] Once the leaflet engaging tip 16 is positioned between the
valve leaflets at the arterial-ventricular junction, the surgeon
selects an actuation mode for the actuation system. In each
successive actuation mode another leaflet, or portion of a leaflet,
is to be grasped and a fastener attached thereto. The surgeon
actuates the vacuum selector 36 to selectively apply a vacuum force
to either the first or second vacuum recess 186, 188 located
proximate to the first or second engaging channel 182, 184 (the
actuated side will depend on which side the vacuum selector 36 is
on). To apply suction to the first vacuum recess 186 the user
positions the vacuum selector 36 to the first position, thereby
causing the first pivoting catch 146 of the force transmission
system 124 to engage the first capture region 162 located on the
first actuation member 156. Simultaneously, the second connecting
rod 138 compressively engages the second vacuum conduit 76 thereby
preventing vacuum flow therethrough. Thereafter, the user depresses
the vacuum actuator 34 causing the compression member 120 of the
vacuum actuation assembly 112 to disengage the compressible main
vacuum line 54, and permitting a vacuum flow through the first
vacuum recess 186 which is in communication with the vacuum main
line 54 through the first vacuum conduit 72. The valve leaflet,
which is located near the first vacuum recess 186, is then captured
by the vacuum force applied thereto. Once the leaflet has been
captured, the user actuates the trigger assembly 90 of the repair
device 10. By actuating the trigger 24, the user causes the first
pivoting catch 146, which is in communication with the actuation
tray 106 of the trigger assembly 90, to retract the first actuation
member 156, thereby causing the first actuation device 214 of the
leaflet engaging tip 16 to retract. Continued actuation of the
trigger 24 causes continued rearward movement of the first
actuation device 214, which results in the first fastener device
218 engaging and traversing the captured valve leaflet. Thereafter,
the first fastener device(s) 218 engages a fastener catch 202
located within the first vacuum recess 186 and is retained therein.
The user then releases the trigger 24, which causes the first
actuation device 214 to return to the extended position. Releasing
the vacuum actuator 34 halts the application of vacuum force
through the first vacuum recess 186 and releases the captured valve
leaflet. The suture material remains positioned through the valve
leaflet where the fastener device(s) 218 had traveled
therethrough.
[0071] The user may then capture another portion of the same valve
leaflet, or another leaflet, by changing the actuation system to
another actuation mode. To capture another leaflet the user moves
the vacuum selector 36 from the first position to the second
position which causes the first pivoting catch 146 to disengage the
first actuation member 156 and causes the second pivoting catch 152
of the force transmission system 124 to engage the second capture
region 164 located on the second actuation member 158.
Simultaneously, the first connecting rod 134 compressively engages
the first vacuum conduit 72 thereby preventing vacuum flow
therethrough while the second connecting rod 138 disengages the
second vacuum conduit 76 thereby permitting a vacuum flow
therethrough. Thereafter, the user depresses the vacuum actuator 34
causing the compression member 120 of the vacuum actuation assembly
112 to disengage the compressible main vacuum line 54, and permits
a vacuum flow through the second vacuum recess 188 which is in
communication with the vacuum main line 54 through the second
vacuum conduit 76. The valve leaflet located near the second vacuum
recess 188 is then captured by the vacuum force applied thereto.
Once the leaflet has been captured, the user actuates the trigger
assembly 90 of the repair device. By actuating the trigger 24 the
user causes the second pivoting catch 152, which is in
communication with the actuation tray 106 of the trigger assembly
90, to retract the second actuation member 158 thereby causing the
second actuation device 216 of the leaflet engaging tip 16 to
similarly retract. Continued actuation of the trigger 24 causes
continued rearward movement of the second actuation device 216
which results in the second fastener device(s) 220 engaging and
traversing the captured leaflet. Thereafter, the second fastener
device(s) 220 engages a second fastener catch 208 located within
the second vacuum recess 188 and is retained therein. The user can
then release the trigger 24 thereby returning the second actuation
device 216 to an extended position. Release of the vacuum actuator
34 halts the application of vacuum force and releases the valve
leaflet. The suture material remains positioned through the valve
leaflet where the fastener device(s) 220 had traveled
therethrough.
[0072] The user can remove the repair device 10 from the patient's
heart. The suture material, which has been positioned through
various portions of the valve tissue remains in place while the
extraneous suture material is feed from the repair device 10 during
removal. Thereafter, a surgical knot may be formed in the
extraneous suture material and advanced to an area within the heart
using a surgical knot pusher, thereby approximating the valve
leaflet tissue. Once the final knot is applied to the area of
interest the extraneous suture material is trimmed and the various
incisions are closed.
[0073] In closing, it is noted that specific illustrative
embodiments of the invention have been disclosed hereinabove. It is
to be understood that the invention is not limited to these
specific embodiments. This specification has focused on the
application of the present inventive devices and methods to the
repair of heart valve leaflets. However, one of skill in the art
will appreciate that the disclosed devices and methods could
alternatively be used to approximate any two pieces of tissue
throughout a patient's body. For example, the present invention may
also used to repair Arterial Septal Defects (ASD), Ventricular
Septal Defects (VSD), and defects associated with Patent Foramen
Ovale (PFO). Accordingly, it should be recognized that the
references to "leaflets" throughout could be equally substituted
for other tissue segments that might require similar approximation
procedures.
[0074] With respect to the claims, it is applicant's intention that
the claims not be interpreted in accordance with the sixth
paragraph of 35 U.S.C. .sctn.112 unless the term "means" is used
followed by a functional statement. Further, with respect to the
claims, it should be understood that any of the claims described
below can be combined for the purposes of the invention.
* * * * *